Entamoeba Spp. IdentificationNCT04466449
Identification of Entamoeba Spp. in Assuit Governorate Hospitals.
An observational study of Entamoeba Spp. Identification, run by Assiut University at 1 site in Egypt.
Trial summary
1. Determination the prevalence of Entamoeba histolytica infections among patients at Assiut University Hospitals presented with diarrhea/dysentery. 2. Evaluatation the role of different cultures in diagnosing Entamoeba . 3. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Entamoeba Spp. Identification
- What is being tested?
- stool sample
- How many people
- 138 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2022to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Male and female patients of different age groups with diarrhea/dysentery attending the outpatient clinics at Assiut University Hospitals
Who may be able to join
- : Male and female patients of different age groups with diarrhea/dysentery attending the outpatient clinics at Assiut University Hospitals .
Who cannot join
- No exclusion criteria .
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Youstina Talaat
Asyut
youstina Talaat, demonestrator, 01225530091, youstinatalaat@yahoo.com
About this study
Official title: Different Methods for Detection and Identification of Entamoeba Species in Assuit Governorate Hospitals.
- Determination the prevalence of Entamoeba histolytica infections among patients at Assiut University Hospitals presented with diarrhea/dysentery.
- Evaluatation the role of different cultures in diagnosing Entamoeba .
- Molecularly differentiation between Entamoeba species to monitor the true prevalence of E.histolytica .
Read the detailed description
Entamoeba histolytica is a common pathogenic protozoan widely distributed throughout the world (10% of the world's population), with 50,000-100,000 deaths reported annually(1) .It is a health problem both in Egypt and worldwide (2) The disease is more prevalent in densely populated areas with poor hygiene requirements and lacking sanitary water supply, especially in rural areas(3). It causes many digestive complications including diarrhea , and fever(2). it transmits through bloodstream forming abscesses in the brain, eye, liver and other vital organs and tissues or even lead to death in some cases . Some individuals have no symptom of the disease but transmit the infection to others(4) It is well- established that E. histolytica leads to invasive disease in humans. Although both E. dispar and E. moshkovskii are still considered to be non pathogenic and free-living amoebas, respectively, some reports suggest their potential role in provoking disease in humans (5) Cysts of E.dispar , E.moshkovskii and E.hartmanni can be confused with E.histolytica. cysts in the parasitological examination(6) The molecular assays, is preferable as it detects E. histolytica , differentiates it from other species and monitors its true prevalence for better treatment and effective control (2)
- Conditions
- Entamoeba Spp. Identification
- Being tested
- stool sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stool sampleDiagnostic test
A stool sample will be collected from each patient for diagnosis of Entamoeba
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination the prevalence of Entamoeba histolytica infections among patients at Assiut University Hospitals presented with diarrhea/dysentery
Different Methods for Detection and Identification of Entamoeba species in Assuit Governorate.
Measured: 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study startSep 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Entamoeba Spp. IdentificationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youstina Talaat Basaly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466449
- Sponsor's protocol ID
- Entamoeba spp. Identification
- Status last verified
- Feb 2022
- First submitted
- 8 Jul 2020
- Last updated
- 9 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Methods for Detection and Identification of Entamoeba Species in Assuit Governorate Hospitals.
- ClinicalTrials.gov ID
- NCT04466449
- Acronym / sponsor ID
- Entamoeba spp. Identification
- Conditions
- Entamoeba Spp. Identification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Determination the prevalence of Entamoeba histolytica infections among patients at Assiut University Hospitals presented with diarrhea/dysentery.
- Evaluatation the role of different cultures in diagnosing Entamoeba .
- Molecularly differentiation between Entamoeba species to monitor the true prevalence of E.histolytica .
Detailed description
Entamoeba histolytica is a common pathogenic protozoan widely distributed throughout the world (10% of the world's population), with 50,000-100,000 deaths reported annually(1) .It is a health problem both in Egypt and worldwide (2) The disease is more prevalent in densely populated areas with poor hygiene requirements and lacking sanitary water supply, especially in rural areas(3). It causes many digestive complications including diarrhea , and fever(2). it transmits through bloodstream forming abscesses in the brain, eye, liver and other vital organs and tissues or even lead to death in some cases . Some individuals have no symptom of the disease but transmit the infection to others(4) It is well- established that E. histolytica leads to invasive disease in humans. Although both E. dispar and E. moshkovskii are still considered to be non pathogenic and free-living amoebas, respectively, some reports suggest their potential role in provoking disease in humans (5) Cysts of E.dispar , E.moshkovskii and E.hartmanni can be confused with E.histolytica. cysts in the parasitological examination(6) The molecular assays, is preferable as it detects E. histolytica , differentiates it from other species and monitors its true prevalence for better treatment and effective control (2)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female patients of different age groups with diarrhea/dysentery attending the outpatient clinics at Assiut University Hospitals
Key inclusion criteria (1 listed)
- : Male and female patients of different age groups with diarrhea/dysentery attending the outpatient clinics at Assiut University Hospitals .
Key exclusion criteria (1 listed)
- No exclusion criteria .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stool sampleA stool sample will be collected from each patient for diagnosis of Entamoeba | Diagnostic test | – |
Primary outcome
Determination the prevalence of Entamoeba histolytica infections among patients at Assiut University Hospitals presented with diarrhea/dysentery
Time frame: 2022
Different Methods for Detection and Identification of Entamoeba species in Assuit Governorate.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Entamoeba Spp. Identification, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youstina Talaat (01225530091, youstinatalaat63@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination the prevalence of Entamoeba histolytica infections among patients at Assiut University Hospitals presented with diarrhea/dysentery (time frame: 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.